Bellicum Reports Fourth Quarter 2021 Financial Results and Provides Operational Update
Bellicum Pharmaceuticals (BLCM) reported a confirmed partial response in one of the first three metastatic castration-resistant prostate cancer (mCRPC) patients treated with BPX-601 in a Phase 1/2 study. Positive safety profile observed for BPX-603 in HER2+ tumors. A $35 million private placement is expected to extend cash runway into Q2 2023, funding ongoing clinical trials. Financially, Q4 2021 revenues were $0.5 million, with a net loss of $9.7 million. The company's cash position stood at $47.7 million, expected to cover operations into Q2 2023.
- Confirmed partial response in one mCRPC patient from BPX-601 trial.
- Favorable safety profile for BPX-603 in early trials.
- Successful $35 million private placement to extend cash runway.
- Reduction in R&D and G&A expenses compared to 2020.
- Net loss increased to $9.7 million in 2021 from $7.7 million in 2020.
- Total revenues remained low at $6.2 million for the full year 2021.
- Omicron variant impacted clinical trial enrollments.
- Confirmed partial response in one of the first three metastatic castration-resistant prostate cancer (mCRPC) patients treated with BPX-601 in Phase 1/2 study -
- Favorable safety profile observed in initial dose cohort of BPX-603 in HER2+ solid tumors -
- Previously reported
HOUSTON, March 24, 2022 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today reported financial results for the fourth quarter and full year 2021 and provided an operational update.
“Bellicum made great progress in the past year in the clinical development of our GoCAR-T® cell therapies and in broadening the impact of our technology via licensing,” said Rick Fair, President and Chief Executive Officer. “In 2021, we opened the BPX-601 trial in prostate cancer and reported a confirmed response in the first cohort treated, initiated the BPX-603 trial in HER2+ solid tumors, signed licensing agreements for our CaspaCIDe safety switch for use in six new CAR-T and CAR-NK programs, and raised additional capital expected to fund the company beyond our next data milestones for our GoCAR-T programs. The Omicron COVID-19 variant had a significant impact on our clinical trial sites and trial enrollment over the last two quarters, but we have recently seen an uptick in site activation and screening activity as cases decline. We believe we are well positioned to further demonstrate the value of GoCAR-T in the coming year.”
Program Highlights and Current Updates
BPX-601 GoCAR-T®
- Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing. On December 6, 2021, Bellicum provided an interim data update and reported that one of the first three mCRPC patients treated in the study achieved a confirmed partial response by RECIST v1.1 criteria. Additionally, no dose-limiting toxicities were observed. The company expects to present a data update on BPX-601 in the first quarter of 2023.
BPX-603 GoCAR-T
- Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate that incorporates Bellicum’s iMC activation and CaspaCIDe® safety switch technologies. On December 6, 2021, the company reported initial Phase 1 data from this trial demonstrating a favorable safety profile in the first dose cohort of the study. The company expects to present a data update on BPX-603 in the first half of 2023.
Private Placement Completed
- As previously reported, Bellicum entered into an agreement for a
$35 million private placement of equity securities in December 2021 with two biotechnology specialist investment funds. Proceeds from the financing are expected to extend cash runway into the second quarter of 2023 and will be used to support ongoing clinical development of BPX-601 and BPX-603.
Regained Compliance with Nasdaq
- On December 10, 2021, Nasdaq notified Bellicum that it had regained compliance with Listing Rule 5550(b)(1), which requires stockholders’ equity of at least
$2.5 million for continued listing of the company’s common stock. Accordingly, the Company is now in compliance with the continued listing requirements of The Nasdaq Capital Market.
Charity Scripture Named Chief Development Officer
- Dr. Scripture rejoined Bellicum in a full-time capacity effective December 1, 2021 after spending the previous year as VP, Business and Development Operations at ACELYRIN, a private biopharmaceutical company. Previously, Dr. Scripture was Vice President, Clinical & Medical Affairs at Bellicum. Prior to joining Bellicum, Dr. Scripture held clinical development leadership positions at AbbVie/Stemcentrx and Pharmacyclics, and spent almost a decade with Amgen in oncology clinical development and medical affairs.
Financial Results for the Fourth Quarter and Year Ended December 31, 2021
Revenues: Bellicum reported revenue of
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Loss from Operations: Bellicum reported a loss from operations of
Net Income/Loss: Bellicum reported net income of
Shares Outstanding: As of March 21, 2022, Bellicum had 8,552,207 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.
Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company’s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum’s GoCAR-T® product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at www.bellicum.com or follow us on Twitter or LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding Bellicum’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Bellicum’s positioning for demonstrating the value of GoCAR-T in the coming year; the timing of data updates from Bellicum’s ongoing BPX-601 and BPX-603 clinical trials; the use of proceeds from Bellicum’s December 2021 private placement; and Bellicum’s expected cash runway. Various factors may cause differences between Bellicum’s expectations and actual results, including, among others, the impact of the COVID-19 pandemic on Bellicum’s clinical trial sites and trial enrollment, other factors, such as safety issues, may impact Bellicum’s clinical progress, actual expenses incurred may be higher than anticipated, and trial results may be different than anticipated, as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the Securities and Exchange Commission, including without limitation Bellicum’s annual report on Form 10-K the year ended December 31, 2021 and in Bellicum’s subsequent filings with the SEC. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update Bellicum’s forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Bellicum Pharmaceuticals
Investors:
Robert H. Uhl
Managing Director
ICR Westwicke
858-356-5932
Robert.uhl@westwicke.com
BELLICUM PHARMACEUTICALS, INC. | |||||||
Consolidated Balance Sheets | |||||||
(Unaudited; in thousands) | |||||||
December 31, | December 31, | ||||||
2021 | 2020 | ||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 46,156 | $ | 35,495 | |||
Restricted cash | 1,501 | 1,501 | |||||
Accounts receivable, interest and other receivables | 205 | 2 | |||||
Prepaid expenses and other current assets | 1,269 | 802 | |||||
Assets held for sale | - | 1,643 | |||||
Non-Current Assets: | |||||||
Operating lease right-of-use assets | - | 645 | |||||
Property and equipment, net | 12 | 189 | |||||
Other assets | - | 307 | |||||
Total assets | $ | 49,143 | $ | 40,584 | |||
Current Liabilities: | |||||||
Accounts payable | $ | 90 | $ | 891 | |||
Accrued expenses and other current liabilities | 3,849 | 4,165 | |||||
Warrant derivative liability | 2,773 | 10,345 | |||||
Private placement option liability | - | 7,803 | |||||
Current portion of lease liabilities | - | 825 | |||||
Liabilities held for sale | - | 672 | |||||
Long-Term Liabilities: | |||||||
Long-term lease liabilities | - | 344 | |||||
Preferred stock | 18,036 | 18,036 | |||||
Total stockholders' equity (deficit) | 24,395 | (2,497 | ) | ||||
Total liabilities, preferred stock and stockholders' equity (deficit) | $ | 49,143 | $ | 40,584 | |||
BELLICUM PHARMACEUTICALS, INC. | |||||||||||||||
Consolidated Statements of Operations | |||||||||||||||
(Unaudited; in thousands, except share and per share amounts) | |||||||||||||||
Three months ended | Year ended | ||||||||||||||
December 31 | December 31 | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues: | |||||||||||||||
Supply agreement | $ | - | $ | - | $ | 700 | $ | - | |||||||
License revenue | 500 | 500 | 5,500 | 500 | |||||||||||
Total revenues | 500 | 500 | 6,200 | 500 | |||||||||||
Operating Expenses: | |||||||||||||||
Research and development | 4,047 | 8,706 | 23,578 | 39,052 | |||||||||||
General and administrative | 1,551 | 3,436 | 7,010 | 15,531 | |||||||||||
Total operating expenses | 5,598 | 12,142 | 30,588 | 54,583 | |||||||||||
Impairment of property and equipment | - | (1,265 | ) | - | (1,265 | ) | |||||||||
Gain (loss) on dispositions, net | - | (105 | ) | (478 | ) | 3,656 | |||||||||
Loss from operations | (5,098 | ) | (13,012 | ) | (24,866 | ) | (51,692 | ) | |||||||
Interest income | - | - | 32 | 387 | |||||||||||
Interest expense | - | (191 | ) | (4 | ) | (2,659 | ) | ||||||||
Change in fair value of warrant and private placement option liabilities | 7,619 | 31,874 | 15,126 | 46,130 | |||||||||||
Gain on extinguishment of debt | - | 112 | - | 112 | |||||||||||
Other income (expense) | 10 | - | 7 | - | |||||||||||
Net income (loss) | $ | 2,531 | $ | 18,783 | $ | (9,705 | ) | $ | (7,722 | ) | |||||
Less: undistributed earnings to participating securities | (716 | ) | (10,984 | ) | - | - | |||||||||
Net income (loss) attributable to common shareholders | $ | 1,815 | $ | 7,799 | $ | (9,705 | ) | $ | (7,722 | ) | |||||
Net income (loss) per common share attributable to common shareholders, basic | $ | 0.12 | $ | 0.99 | $ | (0.84 | ) | $ | (1.34 | ) | |||||
Net income (loss) per common share attributable to common shareholders, diluted | $ | 0.11 | $ | 0.98 | $ | (0.84 | ) | $ | (1.34 | ) | |||||
Weighted-average shares outstanding, basic | 15,712,196 | 7,873,402 | 11,504,294 | 5,760,159 | |||||||||||
Weighted-average shares outstanding, diluted | 15,817,832 | 7,935,532 | 11,504,294 | 5,760,159 | |||||||||||
FAQ
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